Vaccine to Prevent West Nile Virus Disease
This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in death. The vaccine used in this study contains DNA that instructs the body to produce a small amount of a protein found in WNV. If the body creates resistance or immunity to these proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from the vaccine.
Healthy volunteers between 18 years and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a pregnancy test for women who can become pregnant. Patients undergo the following tests and procedures:
- Vaccine injections: Vaccines are given as injections in the upper arm, using a needleless system called the Biojector 2000. The first injection is on study day 0, the second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at least 21 days between injections. The pregnancy test for women of childbearing potential is repeated the day of each vaccine injection.
- Diary card: Participants are given a 5-day diary card after each injection to record their temperature and any symptoms and side effects they may experience for up to 5 days after the injection. The diary cards are returned to the clinic at visits scheduled 2 weeks after each injection. Side effects and symptoms also must be reported immediately to a study nurse or doctor, and a clinic visit may be required for an examination.
- Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a medical history, physical examination (if needed) and blood tests. Vital signs and weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and 12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.
Some of the blood drawn during this study is used for genetic tests to see if different types of immune response to a vaccine are related to genetic differences in people.
West Nile Fever
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of the Safety and Immunogenicity of a West Nile Virus Recombinant DNA Plasmid Vaccine, VRC-WNVDNA017-00 VP, in Healthy Adult Volunteers|
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||January 2008|
Study Design: This is a Phase I open label study to evaluate safety, tolerability, and immune response of a recombinant DNA vaccine, VRC-WNVDNA017-00-VP. The hypothesis is that this regimen will be safe for human administration and elicit immune responses to the West Nile virus. The primary objective is to evaluate the safety and tolerability in humans of the investigational vaccine. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine.
Product Description: VRC-WNVDNA017-00-VP is composed of a single closed circular DNA plasmid that encodes the WNV viral proteins precursor transmembrane (PrM) and envelope (E). Vaccine vials will be supplied at 4 mg/mL. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (in deltoid muscle) using the Biojector 2000 Needle-Free Injection Management System.
Subjects: Healthy adult volunteers (18 to 50 years old) will be enrolled.
Study Plan: Fifteen volunteers will be enrolled and receive 3 injections on the schedule shown in the schema. The protocol requires nine clinic visits and three telephone follow-up contacts.
Study Duration: 32 weeks clinical follow-up for each participant.
Study Endpoints: The primary endpoint is safety of the regimen; secondary immunogenicity endpoints are an ELISPOT and an intracellular cytokine staining (ICS) assay for WNV-specific T cell responses and a WNV ELISA assay. The principal timepoints for ICS and ELISPOT are Week 0 (baseline), Week 8 and Week 12. ICS and ELISPOT at other study timepoints, as well as other immunogenicity assays through Week 32, will be completed as exploratory evaluations. Stored sera will be tested for WNV neutralizing antibody once an assay is developed.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|